Psoriasis Clinical Trial

Efficacy and Safety Study of Guselkumab in the Treatment of Participants With Active Psoriatic Arthritis (PsA)

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of guselkumab in participants with Active Psoriatic Arthritis (PsA).

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Full Description

This is a multi-center (more than one clinical site will work on a medical research study), randomized (study medication assigned to participants by chance), double-blind (neither investigator nor participant knows which treatment the participant receives), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) study to determine the efficacy and safety of guselkumab in participants with PsA. The study will consist of 4 parts: Screening period (6 weeks), a double-blind treatment period (consists of guselkumab and placebo treatment for 24 weeks), an active treatment period (guselkumab for 20 weeks), and follow-up period (12 weeks). The maximal study duration for a participant will not exceed 62 weeks including the Screening period. Eligible participants will be randomly assigned to one of two groups in a 2:1 ratio to either receive Guselkumab 100 milligram (mg) at Weeks 0, 4 then every 8 weeks or Placebo at Weeks 0, 4 then every 8 weeks until Week 24. At week 24, participants remaining in the placebo group will start to receive guselkumab 100 mg at Weeks 24, 28, 36 and 44. Participants in both treatment groups who have less than (<) 5 percent (%) improvement from baseline in both tender and swollen joint counts at Week 16 will qualify for early escape and will switch to open-label therapy with ustekinumab 45 mg or 90 mg at Weeks 16, 20, 32, and 44 based on the approved dosage for the PsA indication in the particular country of study. The efficacy will be assessed primarily by measuring percentage of participants who achieve an American College of Rheumatology (ACR) 20 Response at Week 24. Participants' safety will be monitored throughout the study.

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Eligibility Criteria

Inclusion Criteria:

Has had Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study drug and meet classification criteria for Psoriatic Arthritis (CASPAR) at Screening

Had active PsA as defined by:

At least 3 swollen joints and at least 3 tender joints at Screening and at baseline
C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram (mg)/deciliter (dL) at Screening from the central laboratory
Has at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
Has plaque psoriasis with body surface area (BSA) involvement greater than or equal to (>=) 3% at Screening and baseline
Has active PsA despite current or previous non-biologic disease-modifying antirheumatic drugs (DMARD), oral corticosteroid, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
If using methotrexate (MTX), oral corticosteroids or NSAIDs, the dose must be stable

Exclusion Criteria:

Have other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic lupus erythematosus, or Lyme disease
Has previously received guselkumab or ustekinumab
Has received more than 1 type of biologic anti-tumor necrosis factor (TNF) agent previously
Have received infliximab (or its biosimilars) or golimumab intraveneous (IV) within 12 weeks before the first administration of study drug
Have received adalimumab (or its biosimilars), golimumab subcutaneous (SC), certolizumab pegol or etanercept (or its biosimilars) within 8 weeks before the first administration of study drug

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

149

Study ID:

NCT02319759

Recruitment Status:

Completed

Sponsor:

Janssen Research & Development, LLC

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There is 1 Location for this study

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Huntsville Alabama, , United States

Trumbull Connecticut, , United States

Clearwater Florida, , United States

Tampa Florida, , United States

Sandy Springs Georgia, , United States

Indianapolis Indiana, , United States

Boston Massachusetts, , United States

Edina Minnesota, , United States

Saint Louis Missouri, , United States

Wyomissing Pennsylvania, , United States

Jackson Tennessee, , United States

Arlington Virginia, , United States

Barrie Ontario, , Canada

London Ontario, , Canada

Peterborough Ontario, , Canada

Waterloo Ontario, , Canada

Berlin , , Germany

Hamburg , , Germany

Herne , , Germany

Kiel , , Germany

Köln , , Germany

Lubeck , , Germany

Bialystok , , Poland

Elblag , , Poland

Poznań , , Poland

Warszawa , , Poland

Bucharest , , Romania

Bataysk , , Russian Federation

Moscow , , Russian Federation

Novosibirsk , , Russian Federation

Ryazan , , Russian Federation

Saratov , , Russian Federation

St. Petersburg , , Russian Federation

Ufa , , Russian Federation

Ulyanovsk , , Russian Federation

Yaroslavl , , Russian Federation

Barcelona , , Spain

Madrid , , Spain

Sabadell , , Spain

Santiago de Compostela , , Spain

Sevilla , , Spain

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

149

Study ID:

NCT02319759

Recruitment Status:

Completed

Sponsor:


Janssen Research & Development, LLC

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